What NIH Can Learn from EU Plain Language Summaries

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By Kimbra Edwards, Senior Director, Health Communication Services, CISCRP, and Malgorzata Sztolsztener, Director, Patient Communication, AstraZeneca

Returning research results in plain language is an opportunity to demonstrate respect, gratitude, and transparency to research participants and help strengthen trust. As the NIH develops its plain language summary policy, what can we learn from years of experience implementing PLS under the EU CTR? This article examines lessons around clarity, participant privacy, understandability, implementation, and planning that could help inform the path forward.

Key Takeaways:

1.

EU CTR experience offers a practical roadmap for NIH policy development

Lessons learned from creating plain language summaries under the EU Clinical Trials Regulation can help the NIH establish clear, consistent, and effective requirements for returning study results to participants.
2.

Clear guidance on content, privacy, and transparency will be critical

The article highlights the need for NIH policies to address how results, safety findings, and participant data should be communicated while balancing transparency with privacy protection.
3.

Successful plain language summaries require more than simple language

Effective summaries depend on thoughtful design, patient-centered testing, strong operational processes, and early planning to ensure research results are understandable, accessible, and meaningful to participants.